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Roche DiagnosticsDaniel O’DayCOO Roche Diagnostics
Vontobel Summer Conference, May 2010
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This presentation contains certain forward-looking statements. These forward-looking statements
may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’,
‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy,
goals, plans or intentions. Various factors may cause actual results to differ materially in the future
from those reflected in forward-looking statements contained in this presentation, among others:
1 pricing and product initiatives of competitors;
2 legislative and regulatory developments and economic conditions;
3 delay or inability in obtaining regulatory approvals or bringing products to market;
4 fluctuations in currency exchange rates and general financial market conditions;
5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;
6 increased government pricing pressures;
7 interruptions in production
8 loss of or inability to obtain adequate protection for intellectual property rights;
9 litigation;
10 loss of key executives or other employees; and
11 adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information on our website –www.roche.com
All mentioned trademarks are legally protected
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Pharmaceuticals 9.2 9.7 6 10
Diagnostics 2.4 2.5 7 9
Roche Group 11.6 12.2 6 9
CHF bn
Q1’09 Q1’10 CHF local
% change in
Roche Group
High growth for both divisions
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Q1 ‘09 Q1 ‘10 CHF localCHF m CHF m growth growth
Diagnostics Division
Continues to grow significantly above the IVD market
Professional Diagnostics 1,086 1,170 8% 9%
Diabetes Care 679 708 4% 6%
Molecular Diagnostics 294 294 0% 2%
Applied Science 196 226 15% 19%
Tissue Diagnostics 106 120 13% 21%
Diagnostics Division 2,361 2,518 7% 9%
IVD = in vitro diagnostics
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Roche Diagnostics strategy firmly on track
Accessing novel content is a key driver of differentiation
Expanding menu
• Novel markers
• Companion DxImprovingMedical Value
2000 2010 2020
IncreasingTesting Efficiency
• Automation
• Workflow
• IT
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Trop I, hsTrop T, IL-6, anti-CCP,
PlGF/ SFlt1, tPSA, fPSA
HPV, CT/NG
KRAS Mutations
HER2 SISH & Gastric, MET, EGFR
17 Oncology Antibodies
Strip-free meter (Mobile)
Combined pump & meter (Combo)
cobas 8000Consolidated clinical chemistry &
immunoassays
cobas 4800 Automated PCR
LightCycler 1536High throughput PCR
Influenza A/H1N1
Sequencing reagents
Benchmark Ultra Automated IHC & ISH
Accu-Chek MobileIntegrated blood glucose meter
Innovative product launches - on both fronts
Expand leadership, develop new markets, drive growth
Testing efficiency Medical value
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2009 2010H2 Q2 Q3
c 701
Increasing testing efficiency
Strong launch cobas 8000 modular analyzer series
Phase 1a: Very high volume laboratories
Phase 2:High vol laboratories
EMEA APAC (AUS, NZ, HK)
EMEAAll APACLATAM
US
c = clinical chemistry modules e = Immunoassay modules
c 502
e 602
c 702
Phase 1b: Very high volume laboratories
Q4
EMEA APAC (AUS, NZ, HK) US
e 602
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2008
Accu-Chek Aviva Nano
Accu-Chek Mobile
Accu-Chek Combo
Accu-Chek meters and pumps
Continued roll-out of innovative products driving growth
• Small, sleek design developed for
young, high-frequency testers
• Successful competitor conversions
• Accu-chek Aviva Nano US launch H2
• Only “strip-free” system enabling less steps for greater ease of use
• Available in 12 countries in EU & APAC
• First interactive insulin pump in EU allowing patients to operate pump by meter
• Now launched in 16 markets
Accu-Chek Performa Nano
2009
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The unique Medingo patch-pump technology
Lower hurdles for patients to switch to pump therapy
Bolus
buttons
AdhesiveCannula
• Micro patch-pump: light weight, tubing-free
• Competitive advantages:
– semi-disposable product solution
- easy disconnect & reconnect function
– direct bolus release on pump
• Significantly lower up-front costs for patient
• Launch planned for 2012
Source: Boston Medical Consultants, Company Reports, Roche Analysis
• Insulin delivery market ~CHF 1.6 bn,
growing at +11%
• Insulin patch pump segment estimated to grow over-proportionally
• Patients new to pumps in the U.S. increasingly favor patch-pumpsystems
• Current durable pumps hurdles:
– weight, size, infusion set
– high initial up-front costs
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Creating medical value
Through new diagnostics tests…
Medical Value
• Screening
• Diagnosis
• Prognosis
• Prediction
• Monitoring
• Treatment selection
• Response prediction
• Treatment monitoring
Diagnostics
Companion Diagnostics
+
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Number of HPV tests in the US
~1 m
~28 m
~50 m
Clinical Applications
U.S. Market:$250 m, 20%
growth per year
Pap HPV Colposcopy+ +
- 1 year
Pap/
HPV
+ +
+ 1 year
3 years
Colposcopy
HPV Pap+ +
- 3 years
Colposcopy
ASCUS Triage
Adjunct screening
Primary screening
-
- -
Cervical Cancer: HPV screening algorithms
Growth and market size driven by adoption of screening
Company reports, Roche analysis
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The ATHENA Trial
~47,000 womenFollow-UpYear 1
Follow-UpYear 2
Follow-UpYear 3
2009 - 2010 2010 - 2011 2011 - 2012
Enrolment Completed
ATHENA trial demonstrates medical value of HPV testing and Genotyping in Cervical Cancer screening
• Targets ASCUS triage, adjunct screening
and HPV 16/18 claims
• Study results confirm variability of cytology
and support improved consistency of HPV
DNA based cervical cancer screening
programs
• Data support HPV 16/18 genotyping as
actionable information for intervention
• FDA submission mid 2010; data to be
presented at IPV, Montreal 07/2010
* Wright, TC., EUROGIN 2010
Women with colposcopy (~8,000)
2009
ASCUS/ HPV+
Pap-/ 16/18+Pap-/ HPV +Pap-/ HPV - ASCUS/ 16/18+
ASCUS/ HPV-
Deferred follow up
Yearly follow upImmediate follow up
4.5%5.7%6.1%6.5%CIN 2+ overall
15.5%15.6%15.7%13.8%HR HPV Positive
9.8%8.1%5.2%3.7%Cytology Abnormal
DCBASite
Increasing risk of CIN2+
Cytology vs. HPV Testing*
Immediate follow up for HPV 16/18
ATHENA establishes the value of genotyping in cervical cancer
screening programs2 % 10 %
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Preeclampsia: A significant unmet clinical need
PlGF and sFlt1 - first IVD tests for Preeclampsia
• Leading cause of fetal and maternal death
• Until recently, no specific tests available
• Roche developed first automated test to diagnose women
with preeclampsia by measuring PlGF and sFlt levels2
• Early detection of patients at risk allows closer prenatal
monitoring, early diagnosis and timely intervention
sFlt-1 = soluble fms-like tyrosine kinase; PIGF = placental growth factor1 World Health Organisation 2 available ex-US
• occurs in 3%-7% of
pregnancies
• responsible for 18% of all
maternal deaths in US1
• costs more than $7 bn in
healthcare annually in US1
Preeclampsia
* p < 0.05
Verlohren et al., Am J of Obstetics and Gynecology, 2010
sFlt1/ PlG
Fratio
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Overall survival from Prostate cancer*
70%, n=311
Years of follow-up
Normal
5’ Deletion
5’ Deletion/ 3’ Duplication
Survival from
Pro
state
Cancer %
* Oncogene (2008) 27, 253-263
TMPRSS2= transmembrane protease, serine 2 (androgen responsive gene) ERG=Ets Related Gene
Rearrangement status may determine clinical outcome
• How aggressive is my cancer?
• What should the course of my primary therapy be?
• What is my risk of metastasis?
Prostate Cancer: Rearrangements between TMPRSS2 and ERG genes found in ~50% of prostate cancer patients
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Ventana BenchMark ULTRA
Assay in development for ERG gene rearrangementsIdentifying prostate cancer aggressiveness for appropriate treatment
Imaged Slide Review for Pathologist
5’ Deletion
Likely Aggressive
Normal
Likely Indolent
5’ Deletion and 3’ Duplication
Highly Aggressive
Prostate cancer diagnosis via H&E
3’ Insertion
Likely Aggressive
Ventana SYMPHONY
Oncologist Surgeon
Patient tumor needle biopsy
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Creating medical value
Through Companion Diagnostics…
Medical Value
• Screening
• Diagnosis
• Prognosis
• Prediction
• Monitoring
• Treatment selection
• Response prediction
• Treatment monitoring
Diagnostics
Companion Diagnostics
+
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Strong pipeline of companion diagnostics
Joint Pharma and Diagnostics programs - Oncology
TheraScreen EGFR mutation testEGFRTarceva
TheraScreen KRAS mutation testKRASRG7167 MEK Inh/CIF
PIK3CA
Her1, 2, 3
AREG, BTC
MDM2
p53
BRAF
Biomarker
RG7321 PI3K Inh
RG7422 PI3K Inh
RG1273 Pertuzumab
RG3502 T-DM1
RG7112 MDM2 Antagonist
RG7112 MDM2 Antagonist
RG7204 BRAF Inh/PLX4032
RG7167 MEK Inh/CIF
Pipeline Drug
PCR PIK3CA mutations
FISH PIK3CA copy number assay
cobas MDM2 expression assay
cobas 4800 HER Family
expression assay
AmpliChip p53 array
cobas 4800 BRAF V600E test
Pipeline Assay
List not exhaustive
Roche Pharma targeting multiple pathways
Molecular Tests for assessing presence of mutations offers opportunities to tailor treatment
PIP2PIP2
PPPP
PIP3PIP3
PPPP
PP
SurvivalSurvival
RTK
PP
PP
PP
PP
RTK
FasL
FasL
ForkheadForkheadPP
AKTAKT
Cell cycle progression and proliferation
Cell cycle progression and proliferation
Cyclin D1Cyclin D1
p85p85p110ap110a
PP
PP
PTENPTEN
BadBad
p27
p27
PP
Bcl-2Bcl-2
mTORmTOR
Protein synthesis
and growth
Protein synthesis
and growth
PP
TSC1
TSC1
TSC2
TSC2
PP
PI3KPI3K
mTOR
AKT
RasRas
ERKERKPP
RafRafPP
MEKMEKPP
Raf
MEK
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Mutation in BRAF Kinase
Co-development of test and drug in oncology
• Identifies patients whose tumor DNA carries BRAFV600E mutation
• Increases feasibility of drug clinical development and probability of success
• IVD timelines aligned with RG7204 accelerated development plan → joint launch
* BRAF gene mutations detected in ~8% of all cancers, over 50% of malignant melanomas
Single mutation in BRAF gene
(BRAFV600E) causes activation
in absence of normal growth
factor stimulation
Sample collection &
DNA extraction
BRAFV600E
+ve?
YES
RG7204
Roche Real time PCR
cobas 4800
∼∼∼∼3 hrs
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AmpliChip p53 and MDM2 Antagonist
Identifying patients with non-mutated tumor suppressor protein
* approx. 50% human tumors contain p53 mutants
• Blocking MDM2/ p53 binding enables
p53 activity
• MDM2 antagonist (RG7112) may
require wild-type p53*
Tumor growth
p53
MDM2
Tumor regression
MDM2 antagonist
MDM2MDM2
p53
p53
MDM2
X
X
• Parallel development of
AmpliChip p53 array
• Identifies patients with wild-type
p53 gene
• Essential for RG7112 clinical
development
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Key launches in 2010*
• GS Junior sequencing system (global)• Next-generation ultra-high density NimbleGen microarrays (global)• xCELLigence RTCA HT instrument (global)
Applied Science
• cobas 8000 e 602 & c 702 modules (EU, APAC, LATAM)• cobas 8000 c 701, c 502 and e 602 modules (US)• cobas b 123 for bloodgas & electrolytes (EU)• New immunoassays: 8 (US) 6 (EU)
Professional Diagnostics
• Benchmark GX (EU, APAC)• Molecular probes for Top2a and IGF-1R (EU)• Discovery Ultra for IHC & ISH research (US EU)
Tissue Diagnostics
• cobas TaqScreen DPX blood screening test for B19 virus & HAV (EU)• MRSA Test (US)• CAP/CTM CMV test (EU)
Molecular Diagnostics
• Accu-Chek Aviva Nano (US)• Accu-Chek Mobile (APAC)• Accu-Chek Combo (APAC)
Diabetes Care
Diagnostics Division Outlook: Sales growth significantly above the market
* Subject to appropriate regulatory approvals barring unforeseen events
Roche Investor event, AACC, July 26th
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11%
5%
9%
7%
8%
21%
Japan
Asia Pacific
Latin
America
EMEA*
North
America
Diagnostics
Division
Latin America 6%633
270
118
145
1'352
local sales growthCHF 2,518 m
North America 25%
Asia Pacific 11%
Japan 4%
EMEA1 54%
Q1 2010: Diagnostics Division sales
Growth driven by EMEA and Asia Pacific
1 Europe, Middle East and Africa
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Q1 2010: Diagnostics Division local sales
By Region and Business Area (vs. Q1 2009)
% loc growth
Global North Am. EMEA RoW% loc growth
% loc growth
% loc growth
Professional Diag. 1,170 9 208 6 659 7 303 17
Diabetes Care 708 6 173 1 438 10 97 -2
Molecular Diagnostics 294 2 93 -2 134 4 67 6
Applied Science 226 19 78 8 92 11 56 62
Tissue Diagnostics 120 21 81 20 29 26 10 11
Diagnostics Division 2,518 9 633 5 1,352 8 533 15
Sales CHF m
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Diagnostics Division quarterly sales and local growth1
Q4 ’08 Q1’09 Q2 ’09 Q3 ’09 Q4 ’09 Q1 ’10
1 versus same period of prior year
Professional 1,139 9% 1,086 8% 1,152 9% 1,125 11% 1,190 8% 1,170 9%Diagnostics
Diabetes 764 -7% 679 4% 759 2% 720 7% 811 10% 708 6%Care
Molecular 303 6% 294 7% 300 4% 288 3% 301 4% 294 2%Diagnostics
Applied 223 19% 196 6% 207 11% 213 21% 254 20% 226 19%Science
Tissue 115 n.a. 106 55% 123 18% 117 24% 134 27% 120 21%Diagnostics
DIA Division 2,544 9% 2,361 8% 2,541 7% 2,463 10% 2,690 10% 2,518 9%
Sales CHF m% loc % loc % loc% loc% loc % loc
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2010: Key planned product launches
Professional Diagnostics
Q4EUImproved combination assay for HIV 1 antigen (p24) and HIV antibodies, enabling more reliable early detection of infection with the human immunodeficiency virus
HIV combi 27 min
EU
US
Global
EU
US
EU US
Region
Q4Module for the cobas 8000 modular analyser series. Features automated reagent loading, enabling consolidation of a broader test menu. Throughput: up to 1,900 tests/hour
cobas c 702 advanced clinical chemistry module
Q1-Q4Eight Elecsys immunoassays in the US; six in the EUImmunochemistry menu
TimeDescriptionProduct
Q4Benchtop multiparameter analyser for blood gas, electrolytes, CO-oximetry and metabolites. For use in critical care settings at the point of care
cobas b 123 POCsystem
Q2Automated post analytical sample storage and retrieval modules for bar-coded primary and secondary sample tubes
cobas p 501 and cobas p 701
Q2Modules for the cobas 8000 modular analyser series. Throughput: up to 2,000 and 600 tests/hour, respectively
cobas c 701 and cobasc 502 clinical chemistry modules
Q2Q3
Module for the cobas 8000 modular analyser series for high-volume laboratories. Throughput: up to 170 tests/hour
cobas e 602 immunoassay module
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors.
EU = European Union; EMEA = Europe, Middle East and Africa; APAC = Asia–Pacific; LATAM = Latin America; US = United States.
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2010: Key planned product launches
Diabetes Care
Additional
EU markets
APAC
Additional
EU markets
APAC
US
Region
Q1-Q4
Q1
Q1-Q4
Q1
H2
Time
Interactive insulin delivery system combining an insulin
pump (Accu-Chek Spirit Combo) and a blood glucose
meter (Accu-Chek Aviva Combo) with broad data
management capabilities; the meter also functions as a
pump remote control
Accu-Chek
Combo
DescriptionProduct
Integrated lancing and blood glucose monitoring device employing a unique ‘no strip’ technology that replaces single-use test strips with a continuous tape of 50 tests
Accu-Chek Mobile
Sleeker versions of the Accu-Chek Aviva meter offering an
enhanced feature set
Accu-Chek Aviva Nano
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors.
EU = European Union; EMEA = Europe, Middle East and Africa; APAC = Asia–Pacific; LATAM = Latin America; US = United States.
27
2010: Key planned product launches
Molecular Diagnostics
Q4USSecond-generation test with a unique dual-target design
enabling detection of two separate regions of the HIV-1 genome
Cobas AmpliPrep/
Cobas TaqMan
HIV-1 v2
Q2USAutomated real-time PCR-based test for methicillin-resistant
Stapholococcus aureus
LightCycler MRSA
Advanced Test
US
EU
EU
Region
Q4
Q3
Q3
Time
Viral load monitoring test that will enable physicians to improve
the management of cytomegalovirus (CMV) disease in solid
organ transplant patients
Cobas AmpliPrep/
Cobas TaqMan
CMV
Blood Screening test designed to simultaneously provide a
quantitative result for parvovirus B19 virus and a qualitative
result for hepatitis A virus
cobas TaqScreen
DPX Test
DescriptionProduct
Second generation fully automated HBV test with improved
dynamic range requiring minimal serum and plasma sample
volume
Cobas AmpliPrep/
Cobas TaqMan
HBV v2
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors.
EU = European Union; EMEA = Europe, Middle East and Africa; APAC = Asia–Pacific; LATAM = Latin America; US = United States.
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2010: Key planned product launches
Applied Science
Q1GlobalAutomated high-throughput real-time cell analyses and screening
xCELLigenceRTCA HT instrument
Global
Global
Global
Global
Region
H2
Q2
Q1
Q2
Time
Economical benchtop next-generation DNA sequencing
system for smaller laboratories
GS Junior System
In-solution enrichment capture technology for targeted next-
generation sequencing
SeqCap EZ Exomev.2
DescriptionProduct
Next-generation ultra-high density NimbleGen microarraysArrays
Microarrays for high-resolution analysis of chromosomal
abnormalities; capable of analysing six samples
simultaneously
NimbleGen CGX-6 multiplex arrays
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors.
EU = European Union; EMEA = Europe, Middle East and Africa; APAC = Asia–Pacific; LATAM = Latin America; US = United States.
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2010: Key planned product launches
Tissue Diagnostics
Q2EU, APACEconomical, low-volume advanced tissue staining
platform that automates all slide processing steps
from baking to staining
BenchMark GX
Q2EUFor assessing likelihood of response to Herceptin
treatment in both breast and gastric cancer patients
anti-HER2 neu (4B5)
primary antibody and
HER2 DNA probe
US, EU
APAC, Japan,
LATAM
EU
EU
Region
Q1, Q2
Q4
Q2-Q4
Q2
Time
Enabling target gene detection and control on a
single slide. For use with all molecular markers;
specifically to support HER2 testing.
Dual colour / dual
hapten in situ
hybridisation (ISH) kit
Platform for immunohistochemistry and in situ
hybridisation research, offering significant
improvements in ease of use, workflow and flexibility
Discovery Ultra
DescriptionProduct
For use as an aid in diagnosing and managing breast
and lung cancer
Molecular probes
targeting the enzyme
Top2a & the cell surface
receptor IGF1R
Planned launches may be delayed or not occur as a result of adverse regulatory decisions or other factors.
EU = European Union; EMEA = Europe, Middle East and Africa; APAC = Asia–Pacific; LATAM = Latin America; US = United States.
